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TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer

ConditionHER2-positive Advanced Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

About this trial

TQB2930 is a HER2 bispecific antibody drug. This study aims to evaluate the efficacy and safety of TQB2930 combined with investigator's choice of chemotherapy versus trastuzumab combined with investigator's choice of chemotherapy in subjects with HER2-positive advanced breast cancer who have received at least two prior lines of anti-HER2 therapy in the advanced station.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects voluntarily participate in this study and sign the informed consent form;

Age: 18-75 years (at time of signing Informed Consent Form (ICF); Eastern Cooperative Oncology Group (ECOG) performance status ≤1; estimated life expectancy >3 months;

Cytologically or histologically confirmed Human Epidermal Growth Factor Receptor 2 (HER2)-positive recurrent or metastatic breast cancer;

Received ≥2 prior lines of anti-HER2 targeted therapy in the advanced setting;

Disqualifiers

Other malignancies within 5 years before randomization or concurrent malignancies (except adequately treated non-melanoma skin cancer, in situ cervical cancer, or other cancers with curative treatment and no recurrence for ≥3 years);

Uncontrolled toxicities (>CTCAE Grade 1) from prior therapies (excluding alopecia);

Major surgery, open biopsy, or significant traumatic injury within 28 days before randomization;

Non-healing wounds or fractures;

Trial design

Design model

Parallel

Treatments tested in this trial

  • TQB2930+ chemotherapy

    Drug

    TQB2930 injection is a HER2 bispecific antibody drug； Chemotherapy: Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs.

  • Trastuzumab+ chemotherapy

    Drug

    Trastuzumab is a HER2-specific targeted drug； Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs.

Treatment groups

416 Participants
are divided into 2 treatment groups
Group A: TQB2930+ chemotherapyExperimental treatment 1 intervention
Group B: Trastuzumab+ chemotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

Independent Imaging Review Committee (IRC)-assessed PFS

Time frame
Baseline up to IRC-assessed Disease Progression(PD), approximately 1 years

Secondary outcomes

1

PFS assessed by Investigator

PFS assessed by Investigator

Time frame
Baseline up to Investigator-Assessed investigator, approximately 1 years
2

Overall survival (OS)

From randomization to the time of death from any cause.

Time frame
From date of the first dose until the date of death from any cause, up to approximately 2 years
3

Duration of Response (DOR)

Subjects with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 criteria.

Time frame
From date of the first dose until the date of first documented progression or date of death from any cause, up to approximately 2 years
4

Proportion of subjects achieving partial response (PR)

Subjects with partial response (PR) per RECIST 1.1 criteria.

Time frame
From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first), up to approximately 1 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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